- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870298
Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin (warf-tmp/smx)
December 7, 2015 updated by: University of Pennsylvania
Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1971
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All resident physicians and nurse practitioners involved in inpatient care.
Exclusion Criteria:
None-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: computerized alert
An automatic electronic stop of the tmp/sulfa or warfarin order whenever a resident or nurse practitioner places an order for tmp/sulfa with an already active warfarin order, or when ordering both simultaneously
|
|
Other: 2 Current practice
Current practice of the pharmacist recommending cessation of concurrent warfarin and tmp/sulfa orders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduce concomitant orders for warfarin and tmp/smx
Time Frame: 7 months
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if computerized stop order will increase risk for inadvertent cessation of warfarin
Time Frame: 7 months
|
7 months
|
Determine if computerized stop order will increase risk of delay of treatment with tmp/sulfa when determined to be necessary for treatment
Time Frame: 7 months
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
March 26, 2009
First Submitted That Met QC Criteria
March 26, 2009
First Posted (Estimate)
March 27, 2009
Study Record Updates
Last Update Posted (Estimate)
December 9, 2015
Last Update Submitted That Met QC Criteria
December 7, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Anticoagulants
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Warfarin
- Trimethoprim
- Sulfamethoxazole
Other Study ID Numbers
- 803788
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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